Three Versus 6 Months of Oxaliplatin-Based Adjuvant Chemotherapy for Patients With Stage III Colon Cancer: Disease-Free Survival Results From a Randomized, Open-Label, International Duration Evaluation of Adjuvant (IDEA) France, Phase III Trial

Thierry André 1, 2, 3 Dewi Vernerey 4, 5 Laurent Mineur 6 Jaafar Bennouna 7, 8 Jérôme Desramé 9 Roger Faroux 10 Serge Fratte 4, 11 Marine Hug de Larauze 3 Sophie Paget-Bailly 4 Benoist Chibaudel 1, 3 Jérémie Bez 12 Jérôme Dauba 13 Christophe Louvet 14 Céline Lepère 15 Olivier Dupuis 16 Yves Bécouarn 17 May Mabro 18 J. Egreteau 19 Olivier Bouché 20 Gaël Deplanque 21 Marc Ychou 22, 23 Marie-Pierre Galais 24 François Ghiringhelli 25 Louis Marie Dourthe 26 Jean-Baptiste Bachet 27, 2 Ahmed Khalil 28 Franck Bonnetain 5 Aimery de Gramont 29 Julien Taieb 15, 30, 31
Abstract : Purpose : Reduction of adjuvant treatment duration may decrease toxicities without loss of efficacy in stage III colon cancer. This could offer clear advantages to patients and health care providers. Methods : In International Duration Evaluation of Adjuvant Chemotherapy (IDEA) France, as part of the IDEA international collaboration, patient with colon cancer patients were randomly assigned to 3 and 6 months of modified FOLFOX6 (mFOLFOX6: infusional fluorouracil, leucovorin, and oxaliplatin) or capecitabine plus oxaliplatin (CAPOX) by physician choice. The primary end point was disease-free survival (DFS), and analyses were descriptive. Results : A total of 2,010 eligible patients received either 3 or 6 months of chemotherapy (modified intention-to-treat population); 2,000 (99%) had stage III colon cancer (N1: 75%, N2: 25%); 1,809 (90%) received mFOLFOX6, and 201 (10%) received CAPOX. The median age was 64 years, and the median follow-up time was 4.3 years. Overall, 94% (3 months) and 78% (6 months) of patients completed treatment (fluoropyrimidines ± oxaliplatin). Maximal grade 2 and 3 neuropathy rates were 28% and 8% in the 3-month arm and 41% and 25% in the 6-month arm ( P < .001). Final rates of residual neuropathy greater than grade 1 were 3% in the 3-month arm and 7% in the 6-month arm ( P < .001). There were 578 DFS events: 314 and 264 in the 3- and 6-month arms, respectively. The 3-year DFS rates were 72% and 76% in the 3- and 6-month arms, respectively (hazard ratio [HR], 1.24; 95% CI, 1.05 to 1.46; P = .0112). In the 3 and 6-month arms, respectively, for patients who received mFOLFOX6, the 3-year DFS rates were 72% and 76% (HR, 1.27; 95% CI, 1.07 to 1.51); for the T4 and/or N2 population, they were 58% and 66% (HR, 1.44; 95% CI, 1.14 to 1.82); and for the T1-3N1 population, they were 81% and 83% (HR, 1.15; 95% CI, 0.89 to 1.49). Conclusion : IDEA France, in which 90% of patients received mFOLFOX6, shows superiority of 6 months of adjuvant chemotherapy compared with 3 months, especially in the T4 and/or N2 subgroups. These results should be considered alongside the international IDEA collaboration data.
Keywords : Oncology
Type de document :
Article dans une revue
Liste complète des métadonnées

https://hal-univ-bourgogne.archives-ouvertes.fr/hal-01951156
Contributeur : Lnc - Université de Bourgogne <>
Soumis le : mardi 11 décembre 2018 - 11:45:48
Dernière modification le : jeudi 17 octobre 2019 - 12:33:13

Identifiants

Citation

Thierry André, Dewi Vernerey, Laurent Mineur, Jaafar Bennouna, Jérôme Desramé, et al.. Three Versus 6 Months of Oxaliplatin-Based Adjuvant Chemotherapy for Patients With Stage III Colon Cancer: Disease-Free Survival Results From a Randomized, Open-Label, International Duration Evaluation of Adjuvant (IDEA) France, Phase III Trial. Journal of Clinical Oncology, American Society of Clinical Oncology, 2018, 36 (15), pp.1469-1477. ⟨10.1200/JCO.2017.76.0355⟩. ⟨hal-01951156⟩

Partager

Métriques

Consultations de la notice

47